The FDA Approves New Drug for the Treatment of Colitis and Crohn’s

The Food and Drug Administration recently approved a drug, vedolizumab, which will be sold under the brand name Entyvio, to treat patients with ulcerative colitis and Crohn’s disease.

“The drug is meant for patients who have failed current therapies,” James Cranley MD, of the TriHealth Digestive Institute, explains. “That, in and of itself is exciting, because we’re always looking for more drugs to treat these diseases.”

Vedolizumab: How Does it Work?

Ulcerative colitis is a condition where the lining of the large intestine (colon) and rectum become enflamed, whereas Crohn’s disease is a disorder that can affect any part of the digestive tract.

While the cause of each condition is unclear, we do know that both inflammatory diseases result from the body’s immune system attacking its own intestine (in genetically predisposed individuals). “In order for us to control this disease, we have to suppress your immune system,” Dr. Cranley points out.

Vedolizumab works by blocking the transmission of specific immune cells, leukocytes, which enter the digestive system and cause inflammation. “This (drug) blocks that attraction,” he explains.

Is Vedolizumab Effective?

There have been a few clinical trials, studying the effectiveness of this drug on about 3,000 patients so far, Dr. Cranley says. While the drug has shown improvements in both ulcerative colitis and IBS patients, studies have shown it’s more effective in those with ulcerative colitis.

Right now, researchers haven’t found severe risks or complications associated with taking vedolizumab; however, studies suggests it has adverse side effects, "similar to our current therapies," Dr. Cranley says. There is a rare side effect of a similar medication, natalizumab, called progressive multifocal leukoencephalopathy. "Since the new drug (vedolizumab) does not cross the blood brain barrier, theoretically, the chance of this side effect is felt to be unlikely. However more studies are needed," Dr. Cranley explains.

But, he warns that, like so many other drugs, the uncommon side effects don’t start coming out until the drug is released into the market and millions of people use it.

Bottom Line: Would Dr. Cranley Prescribe Vedolizumab?

“Just like any new drug, we’re always glad to have more options … I think, personally, I will wait, as I often do with any drug that was just released from the FDA, unless I have a patient that has tried everything,” Dr. Cranley explains. ”Currently it is only indicated in patients with moderately severe disease that have failed all current available therapies. I certainly would use it in this situation after exhausting all available therapies."